Trial Outcomes & Findings for Mindfulness-based Smoking Cessation Enhanced With Mobile Technology (NCT NCT04965181)

Results Overview

Self-report of not smoking any combustible tobacco products in the past 7 days (not even a puff), confirmed by expired carbon monoxide \<6 ppm

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

504 participants

Primary outcome timeframe

8 weeks after the start of treatment

Results posted on

2025-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully Participants will receive virtual group counseling based on the Mindfulness-Based Addiction Treatment (MBAT) group protocol, iQuit Mindfully text messages, and nicotine replacement therapy (NRT). MBAT consists of 8 weekly 2-hour sessions. NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke \>10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute "Clearing the Air" booklet and a referral to the Tobacco Cessation Quitline.	iQuit Mindfully Participants will receive iQuit Mindfully text messages and nicotine replacement therapy (NRT). NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke \>10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute "Clearing the Air" booklet and a referral to the Tobacco Cessation Quitline.	Mindfulness-based Addiction Treatment (MBAT) Participants will receive virtual group counseling based on the Mindfulness-Based Addiction Treatment (MBAT) group protocol and nicotine replacement therapy (NRT). MBAT consists of 8 weekly 2-hour sessions. NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke \>10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute "Clearing the Air" booklet and a referral to the Tobacco Cessation Quitline.	Usual Care Participants in the usual care condition are provided with nicotine replacement therapy (NRT). NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke \>10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute "Clearing the Air" booklet and a referral to the Tobacco Cessation Quitline.
Overall Study STARTED	141	146	147	70
Overall Study COMPLETED	122	134	126	61
Overall Study NOT COMPLETED	19	12	21	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mindfulness-based Smoking Cessation Enhanced With Mobile Technology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully n=141 Participants Participants will receive virtual group counseling based on the Mindfulness-Based Addiction Treatment (MBAT) group protocol, iQuit Mindfully text messages, and nicotine replacement therapy (NRT). MBAT consists of 8 weekly 2-hour sessions. NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke \>10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute "Clearing the Air" booklet and a referral to the Tobacco Cessation Quitline.	iQuit Mindfully n=146 Participants Participants will receive iQuit Mindfully text messages and nicotine replacement therapy (NRT). NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke \>10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute "Clearing the Air" booklet and a referral to the Tobacco Cessation Quitline.	Mindfulness-based Addiction Treatment (MBAT) n=147 Participants Participants will receive virtual group counseling based on the Mindfulness-Based Addiction Treatment (MBAT) group protocol and nicotine replacement therapy (NRT). MBAT consists of 8 weekly 2-hour sessions. NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke \>10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute "Clearing the Air" booklet and a referral to the Tobacco Cessation Quitline.	Usual Care n=70 Participants Participants in the usual care condition are provided with nicotine replacement therapy (NRT). NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke \>10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute "Clearing the Air" booklet and a referral to the Tobacco Cessation Quitline.	Total n=504 Participants Total of all reporting groups
Age, Continuous	49.7 years STANDARD_DEVIATION 12.8 • n=174 Participants	49.8 years STANDARD_DEVIATION 12.3 • n=166 Participants	50.3 years STANDARD_DEVIATION 13.1 • n=167 Participants	53.0 years STANDARD_DEVIATION 12.7 • n=164 Participants	50.4 years STANDARD_DEVIATION 12.7 • n=671 Participants
Sex: Female, Male Female	57 Participants n=174 Participants	54 Participants n=166 Participants	56 Participants n=167 Participants	32 Participants n=164 Participants	199 Participants n=671 Participants
Sex: Female, Male Male	84 Participants n=174 Participants	92 Participants n=166 Participants	91 Participants n=167 Participants	38 Participants n=164 Participants	305 Participants n=671 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=174 Participants	6 Participants n=166 Participants	5 Participants n=167 Participants	2 Participants n=164 Participants	18 Participants n=671 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	136 Participants n=174 Participants	140 Participants n=166 Participants	142 Participants n=167 Participants	68 Participants n=164 Participants	486 Participants n=671 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants	0 Participants n=164 Participants	0 Participants n=671 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=174 Participants	0 Participants n=166 Participants	1 Participants n=167 Participants	0 Participants n=164 Participants	1 Participants n=671 Participants
Race (NIH/OMB) Asian	3 Participants n=174 Participants	2 Participants n=166 Participants	4 Participants n=167 Participants	3 Participants n=164 Participants	12 Participants n=671 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants	0 Participants n=164 Participants	0 Participants n=671 Participants
Race (NIH/OMB) Black or African American	94 Participants n=174 Participants	91 Participants n=166 Participants	92 Participants n=167 Participants	48 Participants n=164 Participants	325 Participants n=671 Participants
Race (NIH/OMB) White	34 Participants n=174 Participants	35 Participants n=166 Participants	37 Participants n=167 Participants	16 Participants n=164 Participants	122 Participants n=671 Participants
Race (NIH/OMB) More than one race	6 Participants n=174 Participants	13 Participants n=166 Participants	6 Participants n=167 Participants	1 Participants n=164 Participants	26 Participants n=671 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=174 Participants	5 Participants n=166 Participants	7 Participants n=167 Participants	2 Participants n=164 Participants	18 Participants n=671 Participants
Cigarettes smoked per day at baseline	14.7 Number of cigarettes per day STANDARD_DEVIATION 7.3 • n=174 Participants	15.4 Number of cigarettes per day STANDARD_DEVIATION 9.8 • n=166 Participants	14.5 Number of cigarettes per day STANDARD_DEVIATION 7.5 • n=167 Participants	13.6 Number of cigarettes per day STANDARD_DEVIATION 7.6 • n=164 Participants	14.7 Number of cigarettes per day STANDARD_DEVIATION 8.2 • n=671 Participants

PRIMARY outcome

Timeframe: 8 weeks after the start of treatment

Self-report of not smoking any combustible tobacco products in the past 7 days (not even a puff), confirmed by expired carbon monoxide \<6 ppm

Outcome measures

Outcome measures
Measure	Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully n=93 Participants Participants receive virtual group counseling based on the Mindfulness-Based Addiction Treatment (MBAT) group protocol, iQuit Mindfully text messages, nicotine replacement therapy (NRT), and self-help materials in addition to regular check-in calls from the research team.	iQuit Mindfully n=108 Participants Participants receive iQuit Mindfully text messages, nicotine replacement therapy (NRT), and self-help materials in addition to regular check-in calls from the research team.	Mindfulness-based Addiction Treatment (MBAT) n=101 Participants Participants receive virtual group counseling based on the Mindfulness-Based Addiction Treatment (MBAT) group protocol, nicotine replacement therapy (NRT), and self-help materials in addition to regular check-in calls from the research team.	Usual Care n=52 Participants Participants in the usual care condition are provided with nicotine replacement therapy (NRT) and self-help materials, in addition to regular check-in calls from the research team.
Number of Participants With Confirmed Smoking Abstinence, 8 Weeks	13 Participants	29 Participants	26 Participants	12 Participants

PRIMARY outcome

Timeframe: 12 weeks after the start of treatment

Self-report of not smoking any combustible tobacco products in the past 7 days (not even a puff), confirmed by expired carbon monoxide \<6 ppm

Outcome measures

Outcome measures
Measure	Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully n=107 Participants Participants receive virtual group counseling based on the Mindfulness-Based Addiction Treatment (MBAT) group protocol, iQuit Mindfully text messages, nicotine replacement therapy (NRT), and self-help materials in addition to regular check-in calls from the research team.	iQuit Mindfully n=123 Participants Participants receive iQuit Mindfully text messages, nicotine replacement therapy (NRT), and self-help materials in addition to regular check-in calls from the research team.	Mindfulness-based Addiction Treatment (MBAT) n=110 Participants Participants receive virtual group counseling based on the Mindfulness-Based Addiction Treatment (MBAT) group protocol, nicotine replacement therapy (NRT), and self-help materials in addition to regular check-in calls from the research team.	Usual Care n=55 Participants Participants in the usual care condition are provided with nicotine replacement therapy (NRT) and self-help materials, in addition to regular check-in calls from the research team.
Number of Participants With Confirmed Smoking Abstinence, 12 Weeks	17 Participants	27 Participants	22 Participants	9 Participants

PRIMARY outcome

Timeframe: 24 weeks after the start of treatment

Self-report of not smoking any combustible tobacco products in the past 7 days (not even a puff), confirmed by carbon monoxide \< 6ppm and saliva cotinine \< 20 ng/ml